Date: 2015-07-19
Type of information: Presentation of results at a congress
phase: 1-2a
Announcement: presentation of results at the "2015 Towards an HIV Cure" symposium, organised by the International AIDS Society in Vancouver
Company: Innavirvax (France)
Product: VAC-3S immunotherapy
Action
mechanism: immunotherapy product. The VAC-3S vaccine is intented to induce sustainable levels of anti-3S peptide antibodies in patients, therefore blocking the 3S peptide-mediated pathway of CD4+ T lymphocyte depletion. 3S is a short and conserved peptide from the gp41 envelope protein of the HIV-1 and was shown to be responsible for the loss of CD4+ T lymphocytes in HIV infected patients. The VAC-3S vaccine will not have a direct effect on the virus replication and propagation itself. It will protect the CD4+ T lymphocytes from being depleted and also reduce immune activation. Basically it will protect the immune against deleterious effects of the virus. These effects will be synergistic to that of antiretroviral therapies. This immunotherapy will be used in poor and non immune responders patients under antiretroviral therapy, allowing their CD4+ T lymphocyte count to get to a value above 500/mm3. The poor and non immune responder patients represent a significant proportion of patients under antiretroviral therapies. This therapy will also be used in asymptomatic patients delaying/preventing the patients to be subjected to a decrease of CD4+ T lymphocytes, therefore keeping such patients in the asymptomatic phase, for which there is no associated morbidity.
Disease: HIV/AIDS
Therapeutic area: Infectious diseases
Country: France
Trial
details: IVVAC-3S/P1 was a randomised, double-blind, placebo-controlled dose escalation study of VAC-3S, performed in 33 people living with HIV and receiving antiretroval therapy. Their viral loads were undetectable, and their CD4+ T lymphocyte levels higher than 200 cells/mm3. This study was carried out in two reference centres at Hôpital de la Pitié-Salpêtrière (Professor Christine Katlama, coordinating investigator) and Hôpital Cochin (Professor Odile Launay) in Paris. VAC-3S was administered three times, at four week intervals. Some patients also received a fourth dose, six months after the third. (NCT01549119)
Latest
news: * On July 20, 2015, InnaVirVax, a biopharmaceutical company specialized in research and development of therapeutic and diagnostic solutions for major infectious and chronic diseases, announced the overall results of its Phase I/IIa clinical study (IVVAC-3S/P1) of its VAC-3S immunotherapy, which is currently in development. These results were presented at the "2015 Towards an HIV Cure" symposium, organised by the International AIDS Society in Vancouver. The primary goal of the IVVAC-3S/P1 study was achieved. VAC-3S immunotherapy was very well tolerated and an immune response was demonstrated, the intensity of which was clearly linked to the dose administered. The administration of VAC-3S revealed immunovirological effects on four important markers. A reduction was observed in proviral DNA; this reduction significantly correlated with the immune response to VAC-3S. 24 weeks after the first dose, patients responding to the VAC-3S vaccine showed significant results regarding the following immunological effects: a significant rise in the percentage of CD4+ T-lymphocytes, a key marker for reconstitution of the pool of CD4+ T lymphocytes that are destroyed by HIV; a significant fall in the percentage of CD8+ T lymphocytes, a marker of immune activation that reflects deregulation of the immune system related to the infection. Finally, a significant rise in the CD4/CD8 ratio was observed, this being a marker of immune reconstitution in patients living with HIV. The positive course of all these immune measurements means that a functional cure could be envisioned through the administration of VAC-3S as part of cure strategy. Furthermore, these findings, and notably those concerning the fall in levels of a viral reservoir marker, are very promising. They need to be confirmed in future studies on a larger number of patients. That said, the modulation of virological and immunological markers of HIV infection clearly position the development of VAC-3S as part of a \"functional cure\" strategy designed to allow individuals living with HIV to discontinue their antiretroviral therapy while still controlling their viral load. VAC-3S is currently in phase 2a within the IPROTECT1 clinical study which was initiated in December 2013. Synergistically with VAC-3S development, two diagnostic tests are currently developed by Diaxonhit in the PROTHEVIH consortium. DIAG-3S, a diagnostic test for the detection of anti-3S antibodies naturally secreted by patients infected by the HIV-1 virus. One of Diaxonhit\'s objectives is to validate the use of the level of natural anti-3S antibodies measured by this test as an early marker of disease progression, thus enabling optimized care of HIV-1 infected patients. The DIAG-3S prototype test should be completed during the first half of 2016. Upon completion and validation, commercialization of the test could start independently of the VAC-3S vaccine development. CO-3S, a companion diagnostic for the VAC-3S vaccine which measures the level of anti-3S antibodies in vaccinated patients. This test will enable doctors to measure the immune response to the vaccine therapy, and adjust it accordingly.
